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Abstract:

A method of treating urinary incontinence includes making an incision and
exposing urethral tissue in a patient and employing a tool to place an
implant into the incision. The method also includes coupling a first end
of the implant to the tool and directing the tool and the first end of
the implant through a first obturator foramen of the patient and
following the same approach on a contralateral side of the patient thus
suspending the implant between the first obturator foramen and the second
obturator foramen of the patient. The method additionally includes
elevating a urethra of the patient with a central portion of the implant,
and securing the first end of the implant relative to a first descending
ramus of the patient and securing the second end of the implant relative
to a second descending ramus of the patient.

Claims:

1. A method of treating urinary incontinence, the method comprising:
providing an incontinence treatment device having a support portion
attached on a first side to a first anchor portion and attached on a
second side to a second anchor portion; making an incision and exposing a
bulbar urethra of a patient; employing a first introducer tool and
directing an end of the first anchor portion of the incontinence
treatment device through the incision and through a first obturator
foramen of the patient; employing a second introducer tool and directing
an end of the second anchor portion of the incontinence treatment device
through the incision and through a second obturator foramen of the
patient; applying tension to at least one of the first anchor portion and
the second anchor portion of the incontinence treatment device and
thereby applying compression to the bulbar urethra of the patient with
the support portion of the incontinence treatment device; and anchoring
the incontinence treatment device in the patient by securing the first
anchor portion of the incontinence treatment device near a first ramus
associated with the first obturator foramen of the patient and securing
the second anchor portion of the incontinence treatment device near a
second ramus associated with the second obturator foramen of the patient.

2. The method of claim 1, wherein the incontinence treatment device is an
H-shaped incontinence treatment device comprising a first ascending
anchor portion and a first descending anchor portion attached to a first
edge of the support portion and second ascending anchor portion and a
second descending anchor portion attached to a second edge of the support
portion.

3. The method of claim 1, wherein the incision is a vertical perineal
incision in a male patient.

4. The method of claim 1, wherein the incision is a vaginal incision.

5. The method of claim 1, wherein the first introducer tool follows an
inside-out pass moving through the incision and through the first
obturator foramen of the patient, and the second introducer tool follows
an inside-out pass moving through the incision and through the second
obturator foramen of the patient.

6. A method of treating urinary incontinence, the method comprising:
providing an incontinence treatment device having a support portion
attached between a first anchor portion and a second anchor portion;
making an incision for access to a urethra of a patient; directing an end
of the first anchor portion of the incontinence treatment device through
the incision and through a first obturator foramen of the patient;
directing an end of the second anchor portion of the incontinence
treatment device through the incision and through a second obturator
foramen of the patient; applying tension to the first anchor portion and
the second anchor portion of the incontinence treatment device; and
securing the first anchor portion of the incontinence treatment device
near a first ramus associated with the first obturator foramen of the
patient and securing the second anchor portion of the incontinence
treatment device near a second ramus associated with the second obturator
foramen of the patient.

7. The method of claim 6, wherein the incontinence treatment device is an
H-shaped incontinence treatment device comprising a first ascending
anchor portion and a first descending anchor portion attached to a first
edge of the support portion and second ascending anchor portion and a
second descending anchor portion attached to a second edge of the support
portion.

8. The method of claim 6, further comprising compressing a bulbar urethra
of the patient with the support portion of the incontinence treatment
device.

9. The method of claim 6, comprising wrapping the first anchor portion
around the first ramus associated with the first obturator foramen of the
patient and wrapping the second anchor portion around the second ramus
associated with the second obturator foramen of the patient.

10. The method of claim 6, further comprising elevating and compressing
the urethra of the patient.

11. A method of treating urinary incontinence, the method comprising:
providing an incontinence treatment device having a support portion
attached between a first anchor portion and a second anchor portion;
making an incision and accessing a urethra of a patient; employing a
first introducer tool and directing an end of the first anchor portion of
the incontinence treatment device through the incision and through a
first obturator foramen of the patient; employing a second introducer
tool and directing an end of the second anchor portion of the
incontinence treatment device through the incision and through a second
obturator foramen of the patient; and securing the first anchor portion
of the incontinence treatment device at a locus near a first descending
ramus of the patient and securing the second anchor portion of the
incontinence treatment device at a locus near a second descending ramus
of the patient.

12. The method of claim 11, further comprising tensioning the first
anchor portion and the second anchor portion of the incontinence
treatment device prior to securing the first anchor portion and the
second anchor portion of the incontinence treatment device.

13. The method of claim 11, wherein the incontinence treatment device is
an H-shaped incontinence treatment device comprising a first ascending
anchor portion and a first descending anchor portion attached to a first
edge of the support portion and second ascending anchor portion and a
second descending anchor portion attached to a second edge of the support
portion.

Description:

BACKGROUND OF THE INVENTION

[0001] The present invention is directed to surgical implants for the
treatment of male or female incontinence, and in particular, implantable
slings that are operative to provide sling-type support at or distal to
the bulbar urethral region (male) or midurethral region (female) of a
patient and operatively anchored into position via fixation about the
patient's descending rami.

[0002] Of the estimated 19 million North American adults who have urinary
incontinence, 20% are estimated to be men. Such condition can range in
severity from partial to complete loss of bladder control and patients
afflicted with urinary incontinence can experience varying degrees of
urine loss. In addition, it is known that urinary incontinence may change
over time and that men and women with light incontinence, for example,
may experience minimal leakage during the occurrence of a provocative
event, such as laughing or coughing, whereas men and women with heavy
incontinence may experience continuous urine leakage.

[0003] Generally, urinary incontinence is not considered a disease, but
rather a symptom or side effect of another medical condition. Among the
causes known to cause male urinary incontinence include prostate surgery,
and in particular total prostatectomy, head and spinal cord injury,
infection, certain toxins, such as too much alcohol consumption, certain
medications, such as sedating medications, and certain diseases, such as
cancer, Parkinson's disease and multiple sclerosis. Indeed, male
incontinence can be caused simply by virtue of the aging process or
emotional distress. Female incontinence is caused by weakened and (or)
stretched pelvic muscles, which is associated with childbirth, pregnancy,
trauma, prior surgical procedures, and estrogen loss.

[0004] Each case of incontinence, however, is unique and no two people are
affected by incontinence in the same way. There are, however,
well-recognized types of incontinence and various ways to treat the same.
Stress incontinence, which is the most common type of incontinence,
wherein urine leakage occurs during the occurrence of a provocative
event, such as sneezing, laughing, lifting heavy objects, or when the
patient engages in any type of exercise that puts pressure on the
bladder. Urge incontinence occurs when the patient wants to urinate but
is incapable of exercising restraint until reaching a restroom.
Additional types of incontinence include overflow incontinence, which
occurs when the quantity of urine exceeds the capacity of the patient's
bladder, and functional incontinence, which occurs when the patient has
knowledge of the need to urinate but simply cannot access a restroom
quickly enough due to a physical obstruction or debilitation.

[0005] To treat urinary incontinence, several options are available. Among
the more effective types of recognized treatment include behavioral
techniques, such as biofeedback, bladder training, and pelvic muscle
exercises, and modifications of the patient's diet and fluid intake. With
respect to the latter, it is known that eliminating or cutting back on
certain types of substances, such as caffeine and alcohol, can help
alleviate incontinence. There are additionally medications available,
such as dicyclomine (Bentyl), flavoxate (Urispas), hyoscyamine sulfate
(Anaspaz), imipramine (Tofranil), oxybutynin (Ditropan), tolterodine
(Detrol), and propantheline (Pro-Banthine), phenylpropanolamine
(Dexatrim), and pseudoephedrine (Sudafed) that are helpful in controlling
urinary incontinence.

[0006] Surgery may additionally be an option to treat male and female
urinary incontinence. Along these lines, surgical implants for males,
such as the In-Vance,produced by American Medical Systems, Inc., of
Minneapolis, Minn., is a commercially available surgical implant that is
operative to provide structural support to the urethra for the treatment
of stress incontinence. In this regard, the implant is operative to
provide structural support to the urethra such that during a provocative
event, the implant will provide structural support to the urethra thus
causing the urine to be retained within the bladder and not leak through
the urethra. Likewise, surgical implants for females, such as the In-Fast
Ultra, produced by American Medical Systems, Inc. of Minneapolis, Minn.
is a commercially available surgical implant that is operative to provide
structural support to the urethra for the treatment of stress
incontinence.

[0007] Utilizing sling implants to treat incontinence, however, has been
known to have numerous drawbacks. Securing suburethral sling implants
into position typically requires the use of bone screws, which are
well-known in the art to be difficult and time consuming to deploy, and
can result in significant patient discomfort, especially within the first
couple of weeks following the surgical implantation.

[0008] In addition, implanting suburethral slings are often times
difficult to secure into position with the optimal degree of tension.
Indeed, the implantation of suburethral slings for the treatment of
incontinence is well-recognized as complex, time consuming and can
produce suboptimal clinical outcomes. Moreover, it is well recognized
among surgeons that perform such implant procedures that sutures attached
to bone anchors and/or sutures attached to bone screws utilized to secure
the sling into position frequently break and that often times additional
bone anchors or screws must be secured into position. In fact, each
suture attached to bone anchors and or bone screws must typically be
retensioned two to three times before optimal sling positioning and
structural support to the urethra is achieved.

[0009] Accordingly, there is a substantial need in the art for a
suburethral sling implant for the treatment of incontinence that is
substantially easier to surgically secure into position and that can
further provide an optimal degree of urethral support to thus effectively
treat urinary incontinence. There is additionally a need in the art for
an implant that is of simple construction, easy to surgically manipulate,
and can be manufactured at relative low cost utilizing known implant
materials, whether it be synthetic materials, natural tissues, or
combinations thereof. There is yet a further need in the art for such an
implant that can be secured into position such that the implant defines a
suburethral sling portion operatively positioned at or distal to the
bulbar urethra of the patient (male) or mid-urethral region (female) that
remains anchored into position via the use of an anchoring portion that
extends through the obturator foramen and remain secured at or near the
descending rami of the patient's pelvis without the use of bone anchors.
With respect to the latter, it would be exceptionally advantageous for
such a surgical implant that could be anchored to the pubis through the
obturator foramen preferably via the descending rami thereof.

BRIEF SUMMARY

[0010] The present invention specifically addresses and alleviates the
above identified deficiencies in the art. In this regard, the present
invention is directed to suburethral sling implants and methods of
deploying the same that are effective and substantially easier to deploy
than prior art implants and implantation techniques for treating
incontinence. The implant comprises the combination of a urethral support
portion and at least one anchoring portion. The support portion is
operatively positioned at or distal to the bulbar urethra (male) or
mid-urethral region (female). Per conventional suburethral slings, the
support portion is operative to provide structural support to the urethra
such that during the occurrence of a provocative event, the sling is
operative to compressively engage the urethra to prevent urine leaking
therefrom. The support portion will have a surface area that is at least
2 cm long by 1 cm wide to 8 cm long by 8 cm wide. Along these lines, it
should be understood that the specific dimensions provided herein can
vary by 50% or substantially greater, and retain its ability for use as
an implant.

[0011] The anchor portion extends from the support portion. The anchor
portion, which may take a variety of configurations, is operative to
extend through the obturator foramen of the patient and become secured at
a locus preferably at or near the descending ramus. To effectuate such
attachment, it is contemplated that one or more sutures or other suitable
means for attachment may be utilized to ensure that the anchor portion
becomes secured about the ramus and that the support portion remains
operatively positioned at or distal to the bulbar urethra (male) or
mid-urethral region (female). In a preferred embodiment, the implant will
have at least two anchor portions extending from the support portion with
each respective anchor portion extending through the obturator foramen
and attachable about respective ones of the patient's rami. The anchor
portions will have a width ranging from between 0.5-4 cm and the length
ranging from at least 5.0 cm to 45.0 cm. Along these lines, it should be
understood that the specific dimensions provided herein can vary by 50%
or substantially greater, and retain its ability for use as an implant.
To the extent necessary, both the support and anchor portions of the
implant may be surgically fashioned as necessary to optimize sizing and
configuration of the implant to suit the needs of a specific patient.

[0012] In certain embodiments of the implant of the present invention, the
same may take the form of implants having a central support structure
with anchoring portions extending therefrom in opposed directions or may
be fashioned to have generally "H", inverted "U", or "X" shapes. The
implants may further be provided as generally rectangular, square or
trapezoidal shapes and may further be provided with one or more apertures
to accommodate the attachment of sutures, surgical tacks and the like.
The implants of the present invention may further be fabricated such that
sutures are pre-attached thereto, per the teachings of Applicants'
coowned pending U.S. patent application Ser. No. 10/947,182, entitled
READILY IMPLANTABLE SLING, filed Sep. 22, 2004, the teachings of which
are expressly incorporated by reference. The implants of the present
invention may further be fabricated from any of a variety of surgically
compatible materials well-known in the art, including synthetic
materials, such as synthetic mesh and the like, as well as natural
materials, such as harvested tissues from sources such as animals,
cadavers or the patient himself. The implants may further be fabricated
such that the same are formed from combinations of materials, including
but not limited to combinations of different types of synthetic
materials, combinations of different types of natural tissues and/or
combinations of both synthetic and natural tissues.

[0013] Regardless of the embodiment, in all procedures involving the
implantation of the implants of the present invention, such procedures
are performed with the patient assuming a lithotomy position. A vertical
perineal (male) or vaginal (female) incision is made in the midline
dissecting to expose the bulbar urethra (male) or urethra (female) and
the inferior aspect of the descending rami bilaterally. A surgical
introducer is utilized to introduce the implant into position, typically
through the obturator foramen, in a manner that is substantially easier
and less traumatic than conventional surgical procedures utilized to
access and implant slings for the treatment of male or female
incontinence. Once the surgical site is accessed, the anchoring portion
will preferably be positioned through the obturator foramen and anchored
into position. Surgical sutures and the like may be deployed to
facilitate anchoring of the anchor portions of the implant. Minor
variations wellknown to those skilled in the art may necessarily be made
to effectuate optimal attachment and positioning of the support portion
of the implant, as may be necessary for a given patient. In all cases,
however, the surgical procedures and implants of the present invention
provide a radically more efficient, effective and less traumatic surgical
approach to the treatment of male or female incontinence.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] These and other features and advantages of the various embodiments
disclosed herein will be better understood with respect to the following
description and drawings, in which like numbers refer to like parts
throughout.

[0015] FIG. 1 is a frontal perspective view of a pelvis, a bladder and a
urethra extending therefrom with a sling-type implant shown operatively
secured into position, the implant having a support portion aligned at or
distal to the bulbar urethra and anchoring portions, the latter shown
extending through the obturator foramen and secured about dedicated ones
of the rami of each hip bone.

[0016] FIG. 2 is a side elevational view of the pelvis and implant of FIG.
1 showing a respective one of the anchor portions of the implant secured
about the ramus.

[0017] FIG. 3 is a front elevational view of an implant for the treatment
of male or female urinary incontinence as constructed in accordance with
the present invention.

[0018] FIG. 4 is a front elevational view of an implant for the treatment
of male urinary incontinence as constructed in accordance with another
embodiment of the present invention.

[0019] FIG. 5 is a front elevational view of an implant for the treatment
of male urinary incontinence as constructed in accordance with another
embodiment of the present invention.

[0020] FIG. 6 is a front elevational view of an implant for the treatment
of male or female urinary incontinence as constructed in accordance with
another embodiment of the present invention.

[0021] FIG. 7 is a front elevational view of an implant for the treatment
of male urinary incontinence as constructed in accordance with another
embodiment of the present invention.

[0022] FIG. 8 is a front elevational view of an implant for the treatment
of male urinary incontinence as constructed in accordance with another
embodiment of the present invention.

[0023] FIG. 9 is a front elevational view of an implant for the treatment
of male urinary incontinence as constructed in accordance with another
embodiment of the present invention.

[0024] FIG. 10 is a front elevational view of a pelvis, a bladder and a
urethra extending therefrom with a sling-type implant shown operatively
secured into position, the implant having a support portion aligned at or
distal to the bulbar urethra and anchoring portions, the latter shown
extending through the obturator foramen and secured about dedicated ones
of the rami of each hip bone.

[0025] FIG. 11 is a side elevational view of the pelvis and implant of
FIG. 10 showing a respective one of the anchor portions of the implant
secured about the ramus.

[0026] FIG. 12 is a partial front view of an implant for the treatment of
urinary incontinence as constructed in accordance with another embodiment
of the present invention.

[0027] FIG. 13 is a partial front view of an implant for the treatment of
urinary incontinence as constructed in accordance with another embodiment
of the present invention.

[0028] FIG. 14 is a front elevational view of a photograph of an exemplary
introducer for use with an implant as contemplated in accordance with the
present invention.

[0029] FIG. 15 is a front elevational view of a photograph of an exemplary
introducer for use with an implant as contemplated in accordance with the
present invention.

[0030] FIG. 16 is a front elevational view of a photograph of an exemplary
introducer for use with an implant as contemplated in accordance with the
present invention.

[0031]FIG. 17 is a front elevational view of a photograph of an exemplary
introducer for use with an implant as contemplated in accordance with the
present invention.

[0032]FIG. 18 is a front elevational view of a photograph of an exemplary
introducer for use with an implant as contemplated in accordance with the
present invention.

[0033]FIG. 19 is a front elevational view of a drawing of an exemplary
transvaginal or transperineal tool for use with an implant as
contemplated in accordance with the present invention.

DETAILED DESCRIPTION

[0034] Referring now to the drawings, initially to FIG. 1, there is shown
an implant 10 for the treatment of male and female incontinence that is
operative to provide suburethral support to thus prevent the leakage of
urine, particularly when the patient experiences a provocative event. In
this respect, the implant 10 is operative to act as a suburethral sling,
as is known in the art, but is advantageously operative to be more easily
secured into position than prior art sling implants. The implants of the
present invention are further capable of being deployed in a manner that
is far less traumatic than prior art sling implants and methods of
surgically implanting the same, and further utilizing a novel attachment
approach that provides for optimal suburethral positioning of the sling
10 in an exceptionally secure manner without the use of bone anchors.

[0035] In its broadest sense, the implants of the present invention
comprise the combination of a urethral support portion and at least one
anchoring portion. The support portion is operatively positioned at or
distal to the bulbar urethra 28 (male) or mid-urethral region (female).
The anchoring portion is operative to secure the support portion into
position to thus provide structural support to the urethra, and
particularly so during the occurrence of a provocative event. To achieve
that end, the anchoring member is generally operative to extend through
the obturator foramen and become secured at at least one and preferably
both of the patient's rami. In preferred embodiments of the invention,
discussed more fully below, the anchor portion will be operatively
interconnectable with the descending ramus of one of the patient's
pelvis. Advantageously, the positioning of the anchor portion against the
descending ramus will be accomplished without the use of bone screws,
which are well-known in the art to be problematic to deploy and utilized
as an attachment point for sutures and the like.

[0036] The implants of the present invention further may take a variety of
embodiments. In certain of the embodiments depicted, the implant will
include first and second attachment portions extending from the support
portion with each attachment portion being operatively extensible through
the obturator foramen and attachable to respective ones of the patient's
descending rami. Such attachment portions may be operative to extend in
opposed directions from the support portion or, alternatively, extend in
generally parallel relation to one another from the support portion. In
certain other embodiments, the support portion anchoring portion may be
formed as a continuous segment or otherwise formed to have a generally
rectangular or trapezoidal shape. Moreover, in certain embodiments, the
implants of the present invention may incorporate the use of sutures or
with other types of surgically implantable structures and the like to
facilitate attachment of the same into position. Specifically, it is
contemplated that such embodiments may rely upon a combination of
structures in combination with certain portions of the implant to
facilitate attachment and positioning thereof.

[0037] For purposes of defining the general parameters of implants of the
present invention, it is presently believed that the support portion of
the implant will define a surface area ranging from a 1 cm width by 2 cm
length to an 8 cm width by 8.0 cm length. With respect to the anchor
portion, the same will preferably define a surface area defined by a 0.5
cm width by 5.0 cm length to an area defined by a 4.0 cm width to a 45.0
cm length. With respect to the latter, it should further be understood
that certain embodiments of the present invention, discussed more fully
below, sutures may be utilized in operative combination with the
anchoring portion or, in certain embodiments, exclusively with the
support portion, to thus define means for attaching and securing the
implant into position. In addition, it should be understood that the
specific dimensions provided herein for both the support and anchor
portions can vary by 50% or substantially greater, and retain their
ability for use as an implant.

[0038] With respect to the fabrication of the implants of the present
invention, the same may be made from either synthetic materials, such as
surgical mesh and the like, natural tissues, such as tissues harvested
from either an animal, cadaverous source or the patient himself, and/or
combinations of synthetic and natural materials. Along these lines, it is
contemplated that the implants of the present invention can be fabricated
consistent with those methods disclosed in Applicant's co-owned and
co-pending U.S. patent application Ser. No. 10/684,861, the teachings of
which are expressly incorporated herein by reference. Along these lines,
it is further contemplated that in certain embodiments of the present
invention, the implants may be prefabricated with slings or sutures
attached thereto, consistent with the teachings of Applicants' co-owned
pending U.S. patent application Ser. No. 10/947,182, entitled READILY
IMPLANTABLE SLING, the teachings of which are likewise incorporated by
reference.

[0039] Bearing the foregoing principles in mind, a detailed explanation is
provided here below with respect to the structure, properties and
functioning of the implants of the present invention. Referring again to
FIG. 1, the implant 10 is situated such that the support portion 12
thereof is operatively positioned over the urethra. The implant 10 as
depicted includes first and second support portions 14, 16 that are shown
extending through the obturator foramen 18 and wrapped about dedicated
ones of the descending rami 20, 22 of hip bones 24, 26, respectively.

[0040] FIG. 2 more clearly depicts such engagement between a respective
one of the anchor portions 14 as extending through the obturator foramen
18 and engaged with descending ramus 20 of hip bone 24. In this regard,
the implants 10 of the present invention generally operate on the
principle of including attachment of the implant into position via an
anchoring mechanism that extends through the obturator foramen and
becoming secured to at least one, and preferably both of the descending
ramus of the patient; however, it should be understood that the
descending ramus locus is not to limit the scope of the present invention
and that attachment to any part of the periphery of the pubis and ischium
may be considered suitable areas to which the implants of the present
invention may be attached. Accordingly, fixation of the anchor portions
at the descending rami or any other structure should not be deemed
limiting in any respect.

[0041] Bearing the foregoing principles in mind, and referring now to
remaining FIGS. 3-9, there are shown various embodiments of the implants
of the present invention. Referring to FIG. 3, implant 300 is defined by
support portion 302 with anchor portions 304, 306 extending in opposed
directions therefrom. According to a preferred embodiment, the support
portion will have a width "A" of approximately 4 cm and a length "B" of
approximately 6 cm. Anchor portions 304, 306 may extend from support
portion 302 via a tapered segment, as shown, and will have a length "C"
of approximately 15 cm and a width "D" of approximately 2 cm. As
discussed above, the implant 300 may be fabricated from either synthetic
and/or natural materials. It should be understood, however, that the
specific dimensions provided herein are not absolute, and variations in
the length and width of both the support portion 302 and anchor portions
304, 306 can be readily made by those skilled in the art. Along these
lines, it should be understood that the specific dimensions provided
herein can vary by 50% or substantially greater, as discussed above, and
retain its ability for use as an implant.

[0042] With respect to the procedure for implanting the implant 300
depicted in FIG. 3, Applicants believe that the best mode for performing
the same will require the patient to assume a lithotomy position. A
vertical perineal incision will be made in the midline dissecting to
expose the bulbar urethra in the inferior aspect of the descending rami
bilaterally. A suitable introducer is then passed from inside out or
outside in through the upper aspect of the obturator foramen. A suture
that is attached to a respective one of the anchor portions 304 or 306 is
threaded through the introducer. The introducer is then retracted and the
suture is pulled until a respective one of the ends of the anchor portion
304 or 306 to which the suture is attached can be grasped. The support
portion 302 is then carried over the bulbar urethral complex and,
thereafter, a second introducer is passed from inside out or outside in
on the contra-lateral side to thus enable the second other respective
anchor portion extends through the obturator foramen. The second
introducer is then retracted and a suture affixed to the respective other
anchor portion extends around the pubic ramus. Once so positioned,
tension is introduced to the implant 300 such that the support portion
302 thereof achieves optimal suburethral compression. The respective ends
of anchor portions 304, 306 are then secured, preferably via attachment
to support portion 302 at the edge of each pubic ramus. To achieve that
end, it is contemplated that a suture with or without an additional
tensioning disc (not shown) is passed through anchor portions 304, 306 to
effectuate such attachment. Referring now to FIG. 4, there is shown a
further embodiment 400 for use in the surgical treatment of male urinary
incontinence. As depicted, the implant 400 includes a support portion 402
with first and second anchor portions 404, 406 depending therefrom in
generally parallel relation to one another and additional anchor portions
404a, 406a, ascending therefrom to define an "H" shape. The implant 400,
as depicted, is preferably formed such that support portion 402 has a
width "F" of approximately 7 cm and a height "G" of approximately 5 cm.
Anchor portions 404, 406 preferably have a length "H" of approximately 30
cm and a width "I" of 1 cm. Additional anchor portions 404a, 406a will
have a width of approximately 1.5 cm and a height "J" of approximately 14
cm, and may preferably be formed as extensions of 404 and 406,
respectively. Again, such dimensions can be varied as may be deemed
appropriate by one skilled in the art. Specifically, it should be
understood that the specific dimensions provided herein can vary by 50%
or substantially greater, and retain its ability for use as an implant.

[0043] In the embodiment depicted, anchor portions 404, 406 are operative
to extend through the retropubic space, from posterior to symphysis, or
may extend via a transobturator route. Anchor portions 404a, 406a are
operative to pass through the rectus fascia from anterior to symphysis.

[0044] In accordance with the best mode discussed above with respect to
implant 300, the surgical procedure for implanting implant 400 will
preferably be conducted with the patient assuming a lithotomy position
whereby a vertical perineal incision will be made in the midline
dissecting to expose the bulbar urethra in the descending pubic rami
bilaterally. The bulbar spongiosis will be left intact. Thereafter,
suprapubic transverse incisions of approximately 1 cm are made, 3 cm
lateral to the midline on either side. A suitable introducer is then
passed from such incisions and tunneled either superficially anterior to
the pubic symphysis or retropubically and caused to exit through the
initial perineal incision. A respective one of the ascending anchor
portions 404a or 406a is attached to a suprapubic introducer 1700 and
pulled through the suprapubic incisions.

[0045] This same maneuver is then repeated for the respective other
ascending anchor portion 404a or 406a. Alternatively, the ascending
anchor portions 404a or 406a may be "lifted up" through the perineal
incisions by attaching them to a transperineal introducer 1800 (FIG. 18)
and tunneling the anchor portions either superficially anterior to the
pubic symphysis or retropubically and causing them to exit along with the
implant through the suprapubic incisions. The procedure using the
transperineal introducer 1800 in this fashion also can be performed
without first creating the suprapubic incisions. In other words, the
transperineal introducer 1800 can itself be used to create an exit
opening in the abdominal area at the time the anchor portions are being
moved suprapubically.

[0046] Hereafter, two new incisions, which are preferably approximately 1
cm above the pubic symphysis are performed. The suitable introducer is
then passed from above, retropubically, and out through the initial
perineal incision. A respective one of the descending anchor portions 404
or 406 is then attached to the introducer and pulled up through such
newly formed incision. Such procedure is repeated with respect to the
other descending anchor portion 404 or 406, which as a consequence
creates two sets of anchor portions, namely, descending anchor portions
404, 406 and ascending portions 404a, 406a in the suprapubic region. The
ascending anchor portions 404a, 406a are then tunneled into the
retropubic anchor portions 404, 406 beneath the skin and thereafter
ascending portion 404a will be surgically connected with descending
portion 404 and ascending portion 406a surgically attached to descending
anchor portion 406. To achieve such surgical attachment, it is
contemplated that such attachment may be attained via the use of sutures.

[0047] In a further refinement of such procedure, it is contemplated that
surgical positioning of descending anchor portions 404, 406 can be
accomplished via the use of a suitable introducer that is passed from
outside in or inside out through the obturator foramen. A suture that is
attached to the distal most end of respective one of anchor portions 404,
406 will be threaded to the introducer. Once the introducer is advanced
through the obturator foramen, the same is retracted with the suture
affixed to the end of descending anchor portion 404 or 406 is pulled
until the end of the anchor portion 404 or 406 can be grasped. A second
suitable introducer is utilized with respect to the surgical positioning
of the respective other anchor portion 404 or 406 on the contra-lateral
side. Once so positioned, anchor portions 404 and 406 can be affixed to
ascending anchor portions 404a, 406a around the descending rami via the
transobturator approach and secured on itself via a suture line.

[0048] Referring now to FIG. 5, there is shown a further embodiment of an
implant 500 falling within the scope of the present invention. As
depicted, the implant includes a support portion 502 and first and second
support portions 504, 506 depending therefrom in generally parallel
relation to define an inverted U-shape. The support portion 502 further
includes first and second apertures 508, 510 formed thereon through which
dedicated sutures 512, 514 extend therethrough. The implant 500 is
preferably fashioned such that the support portion 502 has a length "K"
of approximately 8 cm and a height "L" of approximately 4 cm. Each
respective anchor portion 504 will preferably have a length "M" of
approximately 45 cm in length and a width "N" of approximately 1 cm in
length. Again, the dimensions of such implant can vary as will be
understood by those skilled in the art. Specifically, it should be
understood that the specific dimensions provided herein can vary by 50%
or substantially greater, and retain its ability for use as an implant.

[0049] With respect to the implantation of the implant 500, the same is
again performed with the patient assuming lithotomy position. A vertical
perineal incision is made in the midline dissecting to expose the bulbar
urethra and the descending rami bilaterally leaving the bulbar spongiosis
intact. One centimeter suprapubic transverse incisions are made 3 cm
laterally to the midline on either side. A suitable introducer is then
passed from this "stab wound" and tunneled superficially anterior to the
pubic symphysis (not retropubically) that exits through the initial
perineal incision. A respective one of the sutures 512 or 514 is attached
to the introducer and pulled through the upper "stab" incision. This same
procedure is repeated on the respective other side with respective other
suture 512 or 514. Respective ones of the sutures 512, 514 are tied down
to the rectus fascia in the suprapubic area.

[0050] A suitable introducer is then passed from outside in or inside out
through the obturator foramen. A suture that is attached to a respective
one of the anchor portions 504 or 506 on one side is threaded through
such introducer. The introducer is retracted and the suture is pulled
until the respective one of the ends of either 504, 506 (depending on
which portion is attached) can be grasped. The same procedure is repeated
with respect to the other anchor portion 504 or 506 whereby a second
introducer is passed from outside in or inside out on the contra-lateral
side. Both free ends of anchor portions 504 or 506 will be overlapped and
secured. Along these lines, such anchor portions 504, 506 will be tied
around the descending rami via a transobturator approach and thus secured
to itself via a suture.

[0051] In a variation of the embodiment and procedure discussed above with
respect to implant 500, it is contemplated that as opposed to the use of
apertures 508, 510 with dedicated suture lines 512 and 514 affixed
thereto, the implant 500 may utilize thumb tack-like anchors (not shown)
in the positions of 508 and 510, respectively. Such embodiment will
further preferably include a support portion 502 that has a width "K" of
7 cm as opposed to 8 cm. It should be understood that the specific
dimensions provided herein can vary by 50% or substantially greater, and
retain its ability for use as an implant.

[0052] To implant such embodiment, the patient will assume a lithotomy
position and a vertical perineal incision will be made in the midline
dissecting to expose the bulbar urethra and descending rami bilaterally
leaving the bulbar spongiosis intact. The support portion 502 will be
attached via these thumb tacks positioned where apertures 508 and 510 are
depicted, respectively, on each side of the upper aspect of the
descending rami close to the pubic symphysis.

[0053] A suitable introducer is then passed from outside in or inside out
through the obturator foramen. A suture that is attached to a respective
distal-most end of one of the anchor portions 504 or 506 is threaded
through the introducer. The introducer is then retracted and the suture
is pulled until the distal-most end of a respective one of one of the
anchor portions 504 or 506 can be grasped. This portion of a respective
one of the anchor portions is wrapped around the ramus and tied down to
the support portion. A second introducer is passed from outside in or
inside out on the contra-lateral side and the process is repeated with
respect to the respective other anchor portion 504 or 506. The support
portion 502 is then tacked down at the upper aspect of the descending
rami. The anchor portions 504, 506 are then tied around the descending
rami via the transobturator approach and then secured on itself via
suture attachment.

[0054] Referring now to FIG. 6, a further implant 600 is depicted. As
illustrated, the implant 600 comprises a generally rectangular implant
defining a middle support portion 602 with anchor portions 604, 606
formed integral therewith and defining first and second opposed ends.
According to such implant, the same will preferably be formed to have a
length "O" of approximately 45 cm and a width "P" of approximately 3 cm.
It should be understood that the specific dimensions provided herein can
vary by 50% or substantially greater, and retain its ability for use as
an implant.

[0055] To implant such embodiment 600, a vertical perineal incision is
made in the midline dissecting to expose the bulbar urethra and the
inferior aspect of the descending rami bilaterally while the patient
assumes a lithotomy position. A suitable introducer is passed from
outside in or inside out through a 3 cm groin incision that is chosen
with the finger in the initial perineal incision to pass through the
obturator foramen. A respective end 604 or 606 that is attached to the
introducer tip and advanced within the perineal incision. The introducer
is retracted through the obturator foramen with the respective other end
604 or 606 being grasped at the lateral groin incision site and cut at
skin level. The opposite end 604 or 606 is carried over the bulbar
urethral complex. A second suitable introducer is passed from outside in
or inside out through another 3 cm groin incision on the contra-lateral
side and the process is repeated. The respective ends 604 and 606 of the
implant 600 are cut at the level of the skin at the groin incisions.

[0056] The implant in embodiment 700 depicted in FIG. 7 assumes a
generally rectangular configuration having a width "Q" of 4 cm and a
height "R" of 3 cm. In accordance with the other embodiments, the implant
is preferably secured into position by making a vertical perineal
incision to the midline dissecting to expose the bulbar urethra and the
inferior aspect of the descending rami bilaterally while the patient
assumes a lithotomy position. A suture secured on a UR-6 needle is then
used to bite into the periosteum of the descending rami bilaterally.
Although not shown, there will be four sutures altogether on each side
for a total of 8 secured knots to fix the implant 700 into position. The
lower three sutures on one side are threaded through the implant, which
is placed as high as possible on the bulbar urethral complex. Such lower
three sutures are loosely held to stabilize the sling and the top apical
suture is then placed, one on each side at the junction of the descending
rami to the pubic symphysis. The apical sutures are tied down as tight as
possible. The three lower sutures are then tied down accordingly on each
side.

[0057] In the further embodiment depicted in FIG. 8, the implant 800
assumes a generally trapezoidal having an upper length "S" of
approximately 4 cm, a lower length "T" of approximately 6 cm and a height
"U" of approximately 3 cm. It should be understood that the specific
dimensions provided herein can vary by 50% or substantially greater, and
retain its ability for use as an implant. Such implant is secured in
position via the initial formation of a vertical perineal incision that
is made in the midline dissecting to expose the bulbar urethra and the
descending rami bilaterally leaving the bulbar spongiosis intact. The
implant 800, which will further preferably have access holes 804 formed
thereon, is then placed over the bulbar urethra complex. A fine drill,
such as many of a variety well-known to those skilled in the art, is then
advanced through each of the holes 804 to secure a preloaded suture. The
four sutures that will extend through dedicated ones of the apertures 804
are tied along side of the lateral aspects of the implant 802 to create
two knots on each side. The support portion 802 will then be operative to
provide the necessary degree of suburethral support.

[0058] In FIG. 9, there is depicted yet a further embodiment of an implant
900 useful in the surgical treatment of male and female urinary
incontinence and falling within the scope of the present invention. Such
implant will preferably have the dimensions of a height "V" of 3 cm and a
width of 4 cm, as the same pertains to the urethral support portion 902.
Each anchor portion 904, 906 will preferably have a length "X" of
approximately 20 cm and a width "Y" of 1 cm. Along these lines, it should
be understood that the specific dimensions provided herein can vary by
50% or substantially greater, and retain its ability for use as an
implant. Similar to the embodiment depicted in FIG. 3, such embodiment
900 includes a urethral support portion 902 with two anchor portions 904,
906 extending therefrom in opposed directions. With regard to the best
mode by which Applicants would suggest securing such implant 900 into
position, such surgical procedure would involve the patient assuming a
lithotomy position and, in accordance with the other embodiments
discussed above, a vertical perineal incision would be made in the
midline dissecting to expose the bulbar urethral and the inferior aspect
of the descending rami bilaterally. A suitable introducer would then be
passed from inside out or outside in through the upper aspect of the
obturator foramen. An end portion of a respective one of the anchor
portions 904 or 906 is attached through the introducer. The introducer is
retracted and the respective other end of the respective other anchor
portion 904 or 906 is grasped and a ratchet closure is done, as will be
understood by those skilled in the art. Support portion 902 is carried
over the bulbar urethral complex. Thereafter, a second suitable
introducer is passed from inside out or outside in on the contra-lateral
side and the process repeated with respect to the other respective anchor
portion 904, 906. The ends of the sling are then secured to square-like
portions of the urethral support portion 902 at the edge of the pubic
ramus with a ratchet closure.

[0059] FIGS. 10 and 11 illustrate another embodiment of an implant 1000
positioned in a female patient as contemplated by the present invention.
The implant 1000 is situated such that the support portion 1002 thereof
is operatively positioned over the urethra. The implant 1000 as depicted
includes first and second anchor portions 1004, 1006 that are shown
extending through the obturator foramen 1008 and wrapped about dedicated
ones of the descending rami 1010, 1012 of hip bones 1014, 1016,
respectively.

[0060] FIGS. 12-13 show additional embodiments of the present invention.
FIG. 12 illustrates one embodiment of an implant 1200 comprising a
generally rectangular shape defining a middle support portion 1202 with
anchor portions 1204, 1206 formed integrally therewith and defining first
and second opposed ends. Preferably, the implant 1200 has a length A' of
approximately 45 cm and a width B' of approximately 1.1 cm tapering down
to 0.6 cm at the lateral ends of the implant. It should be understood
that the specific dimensions provided herein can vary by 50% or
substantially greater, and retain its ability for use as an implant.

[0061] FIG. 13 illustrates another embodiment of the present invention
including an implant 1300 defined by a support portion 1302 with anchor
portions 1304, 1306 extending in opposing directions therefrom. This
embodiment includes a support portion with a width C' of approximately
1.65 cm and a length D' of approximately 2 cm. Anchor portions 1304, 1306
may extend from support portion 1302 via a tapered segment (as shown) and
will have a length E' of approximately 20.25 cm and width F' of
approximately 1.1 cm. However, one skilled in the art would understand
that the specific dimensions provided herein may be modified and still
remain within the scope and spirit of the present invention.

[0062] Insertion of an implant may be accomplished with various types of
suitable introducers, including an inside-out transobturator introducer,
a helical transobturator introducer or a hook transobturator introducer
as commercially available from the assignee of the present application.
FIG. 14 shows an embodiment of a pair of inside-out transobturator
introducers 1400, as contemplated herein. FIG. 15 shows an embodiment of
a pair of helical transobturator introducers 1500, as contemplated
herein. FIG. 16 shows an embodiment of a hook introducer 1600 as
contemplated herein. FIG. 17 shows an embodiment of a suprapubic
introducer 1700 as contemplated herein. FIG. 18 shows an embodiment of a
transvaginal (female)/transperineal (male) introducer 1800 as
contemplated herein. One skilled in the art would understand that other
similar tools and methods are contemplated herein that could accomplish
implantation of the implant as described in the present invention.

[0063] The present invention includes methods for placing the implants in
a female patient. In one preferred embodiment using an inside-out
transobturator introducer (FIG. 14) the method begins with a patient
first assuming a lithotomy position then draining the bladder. Next, a
midline longitudinal incision is made in the anterior vagina of the
patient. Thereafter, on one side of the patient, dissection is performed
to expose the inferior and superior surfaces of the urethra and lateral
pelvic sidewalls.

[0064] Dissection should continue by perforating the obturator membrane
with a scissors. If the obturator membrane is not reached after
penetration of about 5 cm, however, the dissection path should be
re-evaluated.

[0065] Next, the physician selects an implant 1000. In this embodiment, a
suture loop (not shown) is attached to each of the anchoring portions
1004, 1006 of the implant. The suture loop of one of the anchoring
portions 1004 is connected to a slot at the tip of the inside-out
transobturator introducer 1400. The inside-out transobturator introducer
1400 is then inserted through the vaginal incision and guided through the
obturator foramen around the posterior surface of the ischial pubic
ramus. The introducer 1400 is further guided around the anterior surface
of the ischial pubic ramus until the tip of the introducer 1400 is
exposed in the vaginal dissection.

[0066] The suture loop is then removed from the slot of the inside-out
transobturator introducer 1400 and the introducer 1400 is removed from
the body.The implant 1000 is then pulled through the pathway created by
the introducer 1400 until the end of the implant is exposed at the
vaginal dissection. Then the physician performs the same steps for the
other side of the patient until the ends of the anchoring portions 1004,
1006 of the implant 1000 are now extending through each obturator foramen
of the patient and terminating at the vaginal dissection.

[0067] Now the physician secures the implant 1000 in the correct position.
In this regard, the implant is first aligned mid-urethrally with an
appropriate instrument (e.g., a urethral dilator or a curved scissors)
placed between the implant 1000 and the urethra to indicate the desired
tension to place on the urethra. While maintaining this tension, the
suture loops of each anchor portion 1004, 1006 of the implant 1000 are
removed and the anchor portions 1004, 1006 are trimmed to the length most
suitable for completing the procedure.

[0068] To complete the procedure, each end of the anchor portions 1004,
1006 may be connected to the support portion 1002 of the implant 1000
with a suture thus securing the implant 1000 around the ischial pubic
ramus. Alternatively, each end of the anchor portions 1004, 1006 may be
left loose along the anterior surface of the ischial pubic ramus, the
surrounding tissue serving to secure these anchor portions 1004, 1006 in
place around the ischial pubic ramus. Finally, any excess vaginal mucosa
in the wound is trimmed and the vaginal incision is closed. If desired,
vaginal packing coated with estrogen and/or antibiotic ointment may be
placed in the wound for a period of time, e.g., 12 hours.

[0069] In a second embodiment of a method in accordance with the present
invention, a hook (FIG. 16) or a helical (FIG. 15) transobturator
introducer is used. In this embodiment, a midline longitudinal incision
is first made in the anterior vagina followed by dissection to expose the
inferior and superior surfaces of the urethra and the lateral pelvic
sidewalls. Blunt finger dissection may be used to develop the existing
plain inferior to the endopelvic fascia.

[0070] On the patient's thigh region, the physician then palpates the
medial .border of the obturator foramen in order to locate the base of
the adductor longus tendon at the level of the clitoris. At this
location, just under the tendon and lateral to the bone, a small incision
is made with a scalpel (e.g., a 15 scalpel). The same small incision is
made in the corresponding location on the other side of the patient. The
physician then takes either a helical or a hook transobturator introducer
1500, 1600 and inserts the introducer through the incision (on one side)
and guides the introducer around the posterior surface of the ischial
pubic ramus until the tip of the helical or hook introducer appears in
the vaginal dissection.

[0071] An implant 1000 is then selected. In one embodiment, the anchoring
portions 1004, 1006 of the implant 1000 will each have a suture loop (not
shown) attached thereto. The suture loop is inserted into a slot at the
tip of the introducer 1500 or 1600 and the introducer is then guided back
along its previous path around the posterior surface of the ischial pubic
ramus back towards the incision made on the patient's abdomen.

[0072] The physician then takes a curved tool, such as a Stewart Crypt
Hook (FIG. 19), a suprapubic introducer 1700, or a transvaginal
introducer 1800 and inserts the curved tool through the vaginal incision
and urges the curved tool along the anterior surface of the ischial pubic
ramus towards the thigh region incision. The user then uses the curved
tool to grab the suture loop from the transobturator introducer. The
curved tool is then pulled back towards the vaginal incision pulling the
anchoring portion of the implant 1000 towards the vaginal incision until
the anchoring portion of the implant is exposed in the vaginal incision.
The suture loop is then removed from the tip of the curved tool and the
transobturator introducer (either hook 1600 or helical 1500) is removed
from the body.

[0073] The same steps are then performed for the opposite side of the
patient until both anchoring portions 1004, 1006 of the implant 1000 are
exposed in vaginal incision.

[0074] Now the physician secures the implant 1000 in the correct position.
In this regard, the implant is first aligned mid-urethrally with an
appropriate instrument (e.g., a urethral dilator or a curved scissors)
placed between the implant 1000 and the urethra to indicate the desired
tension to place on the urethra. While maintaining this tension, the
suture loops of each anchor portion 1004, 1006 of the implant 1000 are
removed and the anchor portions 1004, 1006 are trimmed to the length most
suitable for completing the procedure.

[0075] To complete the procedure, each end of the anchor portions 1004,
1006 may be connected to the support portion 1002 of the implant 1000
with a suture thus securing the implant 1000 around the ischial pubic
ramus. Alternatively, each end of the anchor portions 1004, 1006 may be
left loose along the anterior surface of the ischial pubic ramus, the
surrounding tissue serving to secure these anchor portions 1004, 1006 in
place around the ischial pubic ramus. Finally, any excess vaginal mucosa
in the wound is trimmed and the vaginal incision is closed. The abdominal
incisions are also closed, preferably with Steri-strips or Dermabond. If
desired, vaginal packing coated with estrogen and/or antibiotic ointment
may be placed in the vaginal wound for a period of time, e.g., 12 hours.

[0076] Additional general procedure aspects for pre- and post-procedure
applications are contemplated herein and further described in Applicant's
co-owned and co-pending U.S. patent application Ser. Nos. 10/684,861 and
10/947,182, which are herein incorporated by reference in their
entireties.

[0077] Although the invention has been described in terms of particular
embodiments and applications, one of ordinary skill in the art, in light
of the teaching, can generate embodiments and modifications without
departing from the spirit of or exceeding the scope of the claimed
invention. Accordingly, it is to be understood that the drawings and
descriptions herein are proffered by way of example to facilitate
comprehension of the invention and should not be construed to limit the
scope thereof.